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ARTICLE IN BRIEF

An Institute of Medicine panel found design flaws in all of the available studies on cognitive rehabilitative therapy for traumatic brain injury, but recommended that patients currently in therapy should continue their sessions.

Aspecial committee of the Institute of Medicine (IOM) was unable to find enough quality research to evaluate the effectiveness of cognitive rehabilitative therapy (CRT) for traumatic brain injury, but recommended that patients currently in therapy continue their sessions.

In a new report, the IOM panel said it found design flaws in all of the available studies, making it impossible to recommend any guidelines at this time. Studies have included too few patients, failed to consider the impact of other factors that can influence recovery, such as regular contact and support of family and friends, as well as the patient's prior athletic and cognitive ability, according to the report. Also, because many of the studies have relied on self-reported recall by the injured, the IOM panel said that it is difficult to objectively assess any gains attributable to CRT alone.

When TRICARE, the military's insurance program, announced that it would be denying coverage of CRT late last year based on an internal review of current data, Congress quickly countermanded the Department of Defense (DOD), and ordered that coverage be continued despite questions about its efficacy. The DOD then asked the IOM to review existing data, but it found a lack of quality data in available studies due to a range of issues, including inadequate outcomes data or a even a clear definition of CRT.

The IOM committee panel tried to determine whether CRT is effective across the three levels of traumatic brain injury (TBI) — mild, moderate, and severe — as well as during the three phases of recovery (acute, subacute, and chronic). But current evidence “provides limited support” for the effectiveness of CRT and “is not yet sufficient to develop definitive guidelines for health professionals on how to apply CRT in practice.”

Variations among patient characteristics, severity of injuries, and the application of different types of CRT interventions, as well as the lack of standardized terms for the different forms of CRT, have all hampered research on how any specific CRT intervention helps in long-term recovery, the IOM report concluded.

Nonetheless, the IOM panel recommended ongoing use of CRT while improvements are made in the standardization, design, and conduct of future studies. The committee also recommended investing in more research to better define, standardize, and assess CRT outcomes in larger patient samples, and called for a consensus conference to discuss how best to address these variables. Once standardized definitions are developed, it said the DOD should integrate these into ongoing studies as well as develop a comprehensive registry of CRT interventions, including phone and Internet approaches, according to the report.

RESEARCH DIFFICULTIES

Richard D. Zorowitz, MD, associate professor and chairman of the department of physical medicine and rehabilitation at the Johns Hopkins University School of Medicine Bayview Medical Center in Baltimore, said the report's findings were not surprising given the lack of data on CRT and the range of variables involved.

“I think the IOM report results were to be expected. CRT involves treating individuals with so many different problems such as memory, attention, and executive function, and there are few large studies,” he told Neurology Today in a telephone interview.

“It's not like treating hypertension, where you give a patient a pill and blood pressure goes down. Instead, traumatic brain injury is a very heterogeneous population, so it is more difficult to characterize what works and what doesn't. You have to decide which issues need to be addressed and what may be the best approach to help them. Each patient is different, and may require different interventions.”

In his experience, the intensity of CRT an individual receives is the most important predictor of outcomes, although there are little data to support this. Moreover, relying on patient self-reporting can be problematic for many reasons, he said.

“If you ask the patients, most report some improvement, but it is very difficult to measure. It is difficult to conduct placebo-controlled trials for ethical reasons. Currently, many insurance programs will not cover cognitive rehabilitation. However, cognitive issues may relate back to the ability of a patient to function. But if they can ambulate and don't know where they're going due to cognitive deficits, it is a real problem.”

QUESTIONS ABOUT CRT

Martin L. Rohling, PhD, professor of psychology and director of clinical training at the University of South Alabama in Mobile, was the lead author of a 2009 meta-analysis that found CRT provides little benefit for any TBI other than more serious brain injuries. The report, published in Neuropsychology, identified the same shortcomings in studies that the IOM panel found.

“I was disappointed by the IOM report,” he told Neurology Today in a telephone interview. “The IOM spent a lot of time and money to come out with a report saying essentially what we already knew.”

“Despite thirty years of poor quality research, the IOM recommended continuing coverage, but if CRT was a drug, the Food and Drug Administration would never approve it,” Dr. Rohling said.

“I realize this is not a very popular opinion these days, especially among politicians, and apparently some researchers. It's a political hot potato. I had hoped the IOM would take a harder stance in the report, but taking such a stance would mean saying no to our wounded warriors, and I do not think anyone is willing to do that yet.”

In addition to the shortcomings identified by the IOM, he said most TBI studies have included patients with a range of mild to severe injuries, which only further confounds the data and their usefulness. Moreover, data published by Veterans Administration researchers suggests that there are secondary gains, or incentives, for combat veterans with milder injuries to exaggerate their symptoms, further making accurate conclusions difficult.

“There are many reasons someone injured on the battlefield might continue reporting cognitive difficulties after they have recovered from a head injury, ranging from qualifying for greater disability benefits to just wanting to go home,” he said, adding that studies by military medical researchers estimate that as many as 30 percent and 50 percent of all military TBI patients have exaggerated their symptoms.

Dr. Rohling cited research by Charles W. Hoge, MD, at Walter Reed Army Institute of Research in Silver Spring, MD, and Rodney D. Vanderploeg, PhD, of the Defense and Veterans Brain Injury Center in Tampa, FL, in which they documented high rates of falsified claims of ongoing cognitive difficulties and other disabilities among veterans diagnosed and treated for TBIs.

“I think CRT can be effective for some TBIs, but this is a statement of faith on my part because the data are confounded by the fact that the vast majority of military TBIs are milder and will resolve on their own without CRT,” Dr. Rohling continued. “It's the difference between getting hit by a baseball bat and getting a bruise versus a shattered arm. I am not opposed to using CRT for more serious TBIs, but I am against treating milder injuries that will resolve on their own. The patients with more severe injuries are getting a short shrift when we lump all the cases together in trials.”

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